Freya Pharma Solutions has announced a further strengthening of its intellectual property position for better treatment of women with FSIAD

AMSTERDAM, August 25, 2022 /PRNewswire/ — Freya Pharma Solutions, a late-stage clinical-stage pharmaceutical company focused on developing effective pharmaceutical therapies for women diagnosed with female sexual interest/arousal disorder (FSIAD), has today announced the filing of new patent applications for an improved treatment of FSIAD.

Logo Freya Pharma Solutions

Last year, Freya, Pharma Solutions acquired all intellectual property (IP) on 2 innovative drugs, Lybrido and Lybridos, developed for the treatment of women suffering from FSIAD. With the new patent applications announced today, Freya will significantly strengthen its intellectual property position in this area and add strong additional protection through 2042, extending its valuable lifecycle.

Next Pivotal Phase 3 Trial

Freya Pharma Solutions plans to conduct a pivotal Phase 3 clinical trial to confirm the efficacy and safety of Lybrido in women with FSIAD. In June this year, a clinical trial application was submitted to the European Medicines Agency (EMA) for scientific advice on the upcoming pivotal Phase 3 clinical trial with Lybrido for the treatment of FSIAD. The phase 3 clinical trial will be conducted within the European Union in accordance with good clinical practice and ethical principles set out in the declaration of helsinki. It will comply with the EU Clinical Trials Regulation (No. 536/2014), all other applicable laws and regulations, and the requirements of the relevant Member States where the study is being conducted.

dr. Jan van der MoorenFreya’s chief medical officer, said:

“Lybrido is a unique therapeutic concept, both in its combination of testosterone and sildenafil, as well as in its dual route, dual release, fixed-dose system, and as such achieving the optimal synergy of the two active ingredients. Lybrido will be an innovative drug in a market with very few approved drugs United Statesand no drug being approved in Europe so far. With the new patent applications, Freya will further strengthen its intellectual property position and provide strong protection for effective and safe treatment of women suffering from FSIAD. »

About FSIAD

Low sexual desire is consistently reported as the most common sexual complaint among women. As a result, many women are dissatisfied with their sex life, which often affects their social and emotional well-being. FSIAD is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication of the American Psychiatric Association, as a persistent lack or significant reduction in sexual interest and/or excitement. Individuals can be medically diagnosed after exhibiting a well-defined number of symptoms causing clinically significant distress that have persisted for at least six months. The disorder is specified by level of severity and subtyped as lifelong versus acquired, generalized versus situational.

About Lybrido

A total of 20 phase 1 and phase 2a trials and one large-scale phase 2b trials at 17 research sites in the United States have been conducted to date. These trials investigated the efficacy and safety of two novel on-demand pharmacological treatments that were designed to treat two subgroups of FSIAD: women with low sexual cue sensitivity (Lybrido) and women with overarousal. sexual inhibition (Lybridos). Lybrido increases central sexual motivation and physiological sexual responses, such as vaginal erectile tissue swelling and lubrication. The therapy can be taken “on demand” and helps to increase central sexual motivation 3 to 6 hours after taking it. This treatment consists of a new combination tablet (dual route, dual release and fixed dose) composed of a coating of testosterone for sublingual administration and an internal component containing sildenafil, an inhibitor of phosphodiesterase type 5 (PDE 5). The inner core component is coated with a delayed release matrix to ensure that the peak plasma concentration of sildenafil coincides with the window of increased sexual motivation induced by the testosterone component. Thus, this combination allows an increase in genital arousal by an increase in reactivity to sexual stimuli.

About Freya Pharma Solutions

Freya Pharma Solutions is a late-stage clinical company focused on developing effective pharmaceutical therapies for FSIAD, backed by fifteen years of robust research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Situated at Amsterdam, NetherlandsFreya aims to provide patients with a convenient and personalized “on-demand” solution for this recognized unmet medical need.

Please contact us for more information:
Freya Pharma Solutions, amsterdam
Marcel WijmaExecutive Director
[email protected]

For the media:
LifeSpring Life Science Communication, amsterdam
Leon Melens
Such. : +31 6 538 16 427
Email: [email protected]

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